Technical Project Manager - Next Generation Ventilator Program

About the role

We are recruiting a Technical Project Manager to drive the end-to-end development of a new Class II ventilator. You will be the connective tissue across mechanical, electrical, firmware, industrial design, manufacturing, and regulatory teams, keeping the program aligned, moving forward, and delivering results.

The Opportunity

We are an early-stage company developing disruptive medical technologies that challenge industry norms and dramatically reduce cost and complexity. Our small, hands-on team designs, builds, and validates next-generation medical devices entirely in-house from concept through FDA submission.

If you are motivated by complex problems, rapid iteration, and creating products that make a real impact, this is the place where your work will matter every day.

What You Will Do

• Own day-to-day program execution, including schedule, risk management, deliverables, and cross-team coordination
• Translate product requirements into actionable engineering workstreams and hold teams accountable
• Design reviews, maintain the engineering backlog, and drive decision-making with incomplete information
• Carefully coordinate closely with mechanical, electrical, firmware, and industrial design teams to integrate subsystems
• Manage vendor interactions, including ID and UX firms, PCB vendors, plastics suppliers, sensor suppliers, test labs, and manufacturing partners
• Ensure documentation, DMR, and DHF organization, traceability, and test readiness in accordance with FDA design controls
• Support prototyping, V and V planning, test execution, and system integration when needed. This role is hands-on.

Requirements

• Engineering background, such as ME, EE, BME, CompE, or related field
• Strong technical literacy and the ability to interface directly with engineering teams
• Excellent organizational discipline and a bias for clarity, simplification, and forward progress
• A high ownership mindset and a willingness to run toward problems
• Ability to thrive in a fast-paced, highly collaborative, high-expectation environment

Preferred Experience

• Up to five years of experience in product development or technical project work
• Exposure to electromechanical systems or embedded hardware
• Familiarity with ISO 13485, IEC 60601, risk management, or FDA 510(k) processes
• Experience with prototyping, lab testing, or hands-on engineering work